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Samenvatting van het veiligheidsprofiel
De meest gemelde bijwerkingen tijdens de behandeling zijn slaperigheid, duizeligheid, hoofdpijn, hartkloppingen, blozen, buikpijn, misselijkheid, zwelling van de enkels, oedeem en vermoeidheid.
Lijst van bijwerkingen in tabelvorm
De volgende bijwerkingen zijn waargenomen en gemeld tijdens behandeling met amlodipine met de volgende frequenties: Zeer vaak (≥1 / 10); vaak (≥1 / 100 tot <1/10); soms (≥1 / 1.000 tot <1/100); zeldzaam (≥1 / 10.000 tot <1 / 1.000); zeer zeldzaam (<1 / 10.000).
Binnen elke frequentiegroep worden bijwerkingen gerangschikt naar afnemende ernst:
System organ class |
Frequency |
Adverse reactions |
Blood and lymphatic system disorders |
Very rare |
Leukocytopenia, thrombocytopenia |
Immune system disorders |
Very rare |
Allergic reactions |
Metabolism and nutrition disorders |
Very rare |
Hyperglycaemia |
Psychiatric disorders |
Uncommon |
Depression, mood changes (including anxiety), insomnia |
Rare |
Confusion |
|
Nervous system disorders |
Common |
Somnolence, dizziness, headache (especially at the beginning of the treatment) |
Uncommon |
Tremor, dysgeusia, syncope, hypoaesthesia, paraesthesia |
|
Very rare |
Hypertonia, peripheral neuropathy |
|
Eye disorders |
Common |
Visual disturbance (including diplopia) |
Ear and labyrinth disorders |
Uncommon |
Tinnitus |
Cardiac disorders |
Common |
Palpitations |
Uncommon |
Arrhythmia (including bradycardia, ventricular tachycardia and atrial fibrillation) |
|
Very rare |
Myocardial infarction |
|
Vascular disorders |
Common |
Flushing |
Uncommon |
Hypotension |
|
Very rare |
Vasculitis |
|
Respiratory, thoracic and mediastinal disorders |
Common |
Dyspnoea |
Uncommon |
Cough, rhinitis |
|
Gastrointestinal disorders |
Common |
Abdominal pain, nausea, dyspepsia, altered bowel habits (including diarrhoea and constipation) |
Uncommon |
Vomiting, dry mouth |
|
Very rare |
Pancreatitis, gastritis, gingival hyperplasia |
|
Hepatobiliary disorders |
Very rare |
Hepatitis, jaundice, hepatic enzyme increased* |
Skin and subcutaneous tissue disorders |
Uncommon |
Alopecia, purpura, skin discolouration, hyperhidrosis, pruritus, rash, exanthema, urticaria |
Very rare |
Angioedema, erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome, Quincke oedema, photosensitivity |
|
Unknown |
Toxic Epidermal Necrolysis |
|
Musculoskeletal and connective tissue disorders |
Common |
Ankle swelling, muscle cramps |
Uncommon |
Arthralgia, myalgia, back pain |
|
Renal and urinary disorders |
Uncommon |
Micturition disorder, nocturia, increased urinary frequency |
Reproductive system and breast disorders |
Uncommon |
Impotence, gynaecomastia |
General disorders and administration site conditions |
Very common |
Oedema |
Common |
Fatigue, asthenia |
|
Uncommon |
Chest pain, pain, malaise |
|
Investigations |
Uncommon |
Weight increased, weight decreased |
* meestal consistent met cholestasis
Uitzonderlijke gevallen van extrapiramidaal syndroom zijn gemeld.
Melding van vermoedelijke bijwerkingen
Het melden van vermoedelijke bijwerkingen na autorisatie van het geneesmiddel is belangrijk. Hiermee kan de baten / risicoverhouding van het geneesmiddel continu worden gecontroleerd. Beroepsbeoefenaren in de gezondheidszorg wordt verzocht alle vermoedelijke bijwerkingen te melden via de Yellow Card-regeling op www.mhra.gov.uk/yellowcard of zoeken naar MHRA Yellow Card in de Google Play of Apple App Store.
Product Categorie : Afgewerkte medicijnen > Cardiovasculaire geneesmiddelen en geneesmiddelen in de urine
Privacy statement: Your privacy is very important to Us. Our company promises not to disclose your personal information to any external company with out your explicit permission.
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Privacy statement: Your privacy is very important to Us. Our company promises not to disclose your personal information to any external company with out your explicit permission.